Ovarian Cancer Clinical Trial

Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies

Summary

This study evaluates how lifestyle modifications that may be made to manage chemotherapy side effects in patients with gynecologic malignancies.

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Full Description

Since chemotherapy remains one of the primary treatment modalities for gynecologic malignancies, there is increasing interest in non-pharmacological methods of reducing chemotherapy side effects in cancer patients. Our goal is to increase the knowledge surrounding lifestyle modifications, specifically the fasting mimicking diet, on chemotherapy-related side effects, which may be more acceptable to patients than a previously studied water-only fasting diet. To expand this knowledge, The investigators will focus on patients undergoing chemotherapy for gynecologic malignancies. These patients will be assigned to no dietary restriction (control group) or a 5-day fasting mimicking diet (FMD by L-Nutra) for three days prior to, the day of, and one day following chemotherapy treatments (treatment group). The investigators aim to evaluate the feasibility of a fasting mimicking diet in addition to its metabolic effects on the body, patient reported side effects, patient quality of life, deviations or delays in treatment plans, and hospital admissions. Our hypothesis is that a fasting mimicking diet will significantly decrease chemotherapy-related side effects while providing good quality of life.

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Eligibility Criteria

Inclusion Criteria:

Women
Age 35-70 years old (both inclusive)
Biopsy proven gynecologic malignancy
Scheduled to or currently undergoing chemotherapy, with a minimum of 6 cycles remaining
BMI greater than or equal to 18.5
Adequate renal function (serum creatinine less than 1.5 times the upper limit of normal)
Willing to adhere to a 5-day fasting mimicking diet

Exclusion Criteria:

Pregnant or nursing mothers
Prisoners
Patients with diabetes or history of hypoglycemia
Taking daily medications that cannot be safely taken without food
History of significant or unstable cardiac disease such as congestive heart failure or history of myocardial infarction, stroke or pulmonary embolism within the last 3 months, renal failure, history of - eating disorder, dementia, psychosis, impaired physical mobility.
Significant medical comorbidity that would be dangerous with a fasting mimicking diet.
Any known or suspected food allergies that overlap with the FMD/Transitional diet by L-Nutra meal kit ingredients.

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

30

Study ID:

NCT06376604

Recruitment Status:

Recruiting

Sponsor:

L-Nutra Inc

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There is 1 Location for this study

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The University of Tennessee Medical Center
Knoxville Tennessee, 37920, United States More Info
Jonathan D Boone, MD
Contact
865-305-5622
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

30

Study ID:

NCT06376604

Recruitment Status:

Recruiting

Sponsor:


L-Nutra Inc

How clear is this clinincal trial information?

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